FDAFDA · Food and drugs·Recall number Z-1259-2019
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce:
Published May 8, 2019 · Recall initiated: March 20, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
- Lot
- Mfg. Lot or Serial # System ID Model, Catalogue or Code # DRGX56002 SHIPPED (GON 4683652) H3100BT DDRX34058 909558D670NM H3100AN DDRX34056 650723D670 H3100AN DDRX34053 SHIPPED (AO 1614951) H3100AN DRGX56005 614CVA6702 H3100BT DRGX56017 110002NU06 H3100BT DRGX56004 403343D670A H3100BT DRGX56018 X7410502 H3100BT DRGX56009 083026206531618 H3100BT DRGX56012 STD01300 H3100BT DDRX34055 00362NUC04 H3100AN
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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